(621f) Can A Design Space Be Built On Material Attributes Alone?
AIChE Annual Meeting
2010
2010 Annual Meeting
Comprehensive Quality by Design in Pharmaceutical Development and Manufacture
TI Application of Quality by Design in Drug Product Process Development
Thursday, November 11, 2010 - 9:50am to 10:10am
In April, 2009, the PhRMA Drug Product Technical Group sponsored an industry workshop to explore the practicality and limitations of defining a design space in terms of material attributes rather than process variables. This presentation summarizes and expands on the output of this workshop. A material-attribute design space would be independent of scale and configuration of process equipment and the associated process variables. For this reason, it would be portable in the sense that post-approval changes of equipment scale, nameplate, or location would not require regulatory approval. A hypothetical case study of an immediate release oral tablet is presented to illustrate how such a design space could be constructed and implemented.